Coronavirus | Pfizer withdraws emergency use authorization request for its COVID-19 vaccine in India
DCGI expert panel refused approval on grounds that there had been reports of “paralysis, anaphylaxis and other serious adverse events” after vaccine approval in some other countries
Pfizer India has withdrawn its request to India’s Drug Controller General of India (DCGI) to allow its vaccine to be made available in India, a company spokesperson said on Friday.
On Wednesday, a committee of experts from DCGI refused to approve the vaccine on the grounds that there had been reports of “paralysis, anaphylaxis and other serious adverse events” after the vaccine was approved in some other countries and it was still not clear whether this was related to the vaccination. Additionally, Pfizer India had not defined a plan to generate data on safety and immunogenicity in the Indian population, the committee noted.
“Pfizer will continue to engage with the authority and resubmit its request for approval with additional information as it becomes available in the near future. Pfizer remains committed to making its vaccine available to the Indian government and pursuing the required path for emergency use authorization that enables the availability of this vaccine for any future deployment, ”a company statement said.
The Pfizer-BioNTech mRNA vaccine uses new technology – in the form of a small piece of coronavirus genetic material called messenger ribonucleic acid – to make a vaccine against the coronavirus. Interim Phase 3 efficacy trials in Americans showed that people who were inoculated were 95% more likely to be protected than those who had not taken the vaccine.
After being approved in the United States, the United Kingdom and the European Union, Pfizer also requested that the vaccine be made available in India under “emergency use list” conditions. This is the clause under which Covishield and Covaxin were approved in India. While the latter has been administered to more than 4.5 million Indians, Pfizer India had had the opportunity at least three times, since the end of December, to appear before the Committee of Experts in the matter (SEC) of DCGI to provide sufficient evidence for approval. However, Pfizer had not appeared multiple times, Health Secretary Rajesh Bhushan said early last month.
The US-based Centers for Disease Control and Prevention, which monitors vaccine side effects, said that as of Jan. 18, there were 50 cases of anaphylaxis – a treatable but serious allergic reaction that is extremely rare but can also be fatal – after the Pfizer vaccine. This was about 5 per million doses administered, down from the previously reported rate of 11.1 per million doses administered through December 23.
Bell’s palsy is a treatable condition that causes weakness or temporary paralysis on one side of the face. The United States Food and Drug Administration (FDA) released an analysis of the safety data for the Pfizer / BioNTech vaccine in December. The study involved 38,000 people and saw four develop Bell’s palsy, none in the placebo group developing the disease.
A requirement of the Pfizer-BioNTech vaccine is that it requires sub-zero refrigeration, resulting in increased costs, especially in India. “Now that we have two vaccines available in India and enough stocks so far and underway, the committee felt that reports of anaphylaxis needed to be fully understood before Pfizer vaccine was recommended,” one person said. close to the proceedings of the SEC, which refused identified.